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pharmafile | August 31, 2007 | News story | Sales and Marketing |Â Â Â
Advanced Life Sciences metastatic melanoma drug granted orphan status
The FDA has granted orphan drug designation to Advanced Life Sciences for its metastatic melanoma treatment.
ALS-357 is a novel drug entering phase I/II clinical development that has demonstrated potent anti-tumour activity against malignant melanoma. Rapid tumour regression has been shown in a mouse model and no observable toxicity was seen even at high doses, according to the company. ALS-357 operates by inducing apoptosis, or programmed cell death, in the tumour cells.
"Our phase I/II study, which is currently slated to commence in early 2008, will help determine whether the promising results we observed in preclinical studies can be translated into the human population," commented Michael Flavin, chief executive of Advanced Life Sciences.
Melanoma is estimated to be the sixth most common cancer among new cases of cancer in the US, It accounts for about 4% of all skin cancers but causes about 79% of skin cancer deaths.
Related links:
Advanced Life Sciences Holdings Inc: LSA company profile
Melanoma or Skin Cancer Drug Pipeline Report
The Cancer Market Outlook to 2011
Compugen strikes drug deal with Teva
Compugen has signed an agreement with Teva Pharmaceutical Industries for the development of a treatment for inflammatory diseases.
The agreement covers both an initial research collaboration and an option to Teva for a worldwide exclusive development and commercialisation licence.
CGEN-54, a drug candidate for chronic inflammatory diseases, is one of a large number of novel splice variants predicted in silico using a Compugen discovery engine, and then validated experimentally.
According to the agreement, Compugen will provide Teva with research quantities of the drug. Teva will then conduct further in vivo validation experiments and has received from Compugen an option to enter into an exclusive, worldwide milestone and royalty-bearing licence agreement for the development and commercialisation of any resulting products.
CGEN-54 is an antagonistic variant of MCP1 (monocyte chemoattractant protein 1). MCP1 – also named CCL2 – belongs to the CC protein family. Binding of this protein to its cognate receptor, CCR2, leads to the recruitment of specialised immune cells into the site of inflammation, often leading to chronic inflammation.
CGEN-54 is a novel splice variant of MCP1 which has now been shown to inhibit MCP1 related activity. The companies say the inhibition of the MCP1-CCR2 pathway represents a promising target to effectively modulate disease progression in a number of chronic inflammatory diseases, such as multiple sclerosis.
Related links:
Compugen Ltd: LSA Company profile
Teva Pharmaceutical Industries Ltd: LSA company profile
Autoimmune and Inflammation – Inflammation – Drug Pipeline Report
Commercial and Pipeline Insight: Inflammatory Bowel Disease-Competition Increases for the Biologics
FDA accepts Merck's cholesterol drug for review
Merck & Co.'s new drug application for cholesterol-lowering compound Cordaptive has been accepted for standard review by the FDA, according to the company.
Merck said that it anticipates FDA action in the second quarter of 2008. The company added that it is also moving forward as planned with filings in countries outside the US.
Cordaptive is an investigational compound containing Merck's own extended-release niacin and laropiprant, a novel flushing pathway inhibitor designed to reduce flushing often associated with niacin treatment.
Data included in the application support the proposed use of Cordaptive, either alone or with a statin, as adjunctive therapy to diet for the treatment of elevated LDL cholesterol (LDL-C or "bad" cholesterol), low HDL cholesterol (HDL-C or "good" cholesterol) and elevated triglycerides levels. All are conditions associated with increased risk of heart disease.
Niacin is widely recognised as an effective lipid-modifying therapy; however, treatment has been limited as a result of the flushing side-effect.
Related links:
Merck & Co Inc: LSA Company profile
Cardiovascular and Circulatory System – Arrhythmiasis Drug Pipeline Report
Cardiovascular and Circulatory System – Stroke Drug Pipeline Report
Cardiovascular and Circulatory System – Thrombosis Drug Pipeline Report
The Carrdiovascular Market Outlook to 2011
Lorus takes leukaemia drug to phase II
Lorus Therapeutics is advancing its investigational acute myeloid leukaemia drug to phase II trials after reporting encouraging results from a proof of concept study.
The proof of concept clinical trial demonstrated safety and appropriate dosing of the combination regimen and showed promising clinical responses in patients under 60 years of age. Complete results from the clinical trial are expected to be presented by the investigators in a scientific publication.
The advanced phase II clinical trial, which is now under way, includes both an efficacy study and a novel additional study to measure intracellular target activities and pharmacological synergies between the two agents. In the first stage of the 60-patient trial, the pharmacologic and target-related activity of GTI-2040 and high-dose Ara-C (HiDAC) will be evaluated in two groups, to determine the contribution of each agent alone and in combination.
Ara-C, including HiDAC, is a key component of nearly all AML regimens, for induction, consolidation or salvage treatment. However even with intensification of the Ara-C, response to treatment in refractory and relapsed disease is limited by development of increasing resistance to Ara-C with repeated exposures.
The second stage of the trial will provide efficacy evaluation in a larger patient population. Canadian biopharmaceutical firm Lorus expects the clinical trial to be completed by the end of 2008.
Related links:
Lorus Therapeutics Inc: LSA company profile
Acute Leukaemias – Persistent unmet needs confer significant commercial opportunity
Prolexys begins clinical trials for cancer drug
Prolexys Pharmaceuticals has started a phase I study of its investigational cancer candidate designed to evaluate the safety, pharmacokinetic and pharmacodynamic properties of the drug in patients with advanced solid tumours.
The first phase I study of the compound, PRLX 93936, will be a dose-escalating trial involving up to 36 patients. PRLX 93936 is a structural analogue of a compound called erastin, in-licensed by Prolexys from the MIT/Whitehead Institute in January 2005.
PRLX 93936 was tested against a series of normal and tumour cell lines derived from tumours with dissimilar causative mutations, indicating potent and selective activity against a wide variety of tumours, many with activated Ras pathway.
The compound showed robust tumour regression in a range of human tumour xenografts grown in immuno-compromised mice, including models of pancreatic, colon, and ovarian cancers, and melanoma, fibrosarcoma and other solid tumours.
Related links:
Breast Cancer Drug Pipeline Report
Liver Cancer Drug Pipeline Report
Prostate Cancer Drug Pipeline Report
Innovative and Targeted Cancer Therapies: Key technologies, new applications and leading players
Commercial Insight: Top 20 Cancer Therapy Brands – Sales of targeted therapies
Innovations in Cancer: Novel therapeutics, new diagnostics and future R&D strategies
